Combination herbal product to benefit the respiratory tract in people exposed to smoke

ABSTRACT

An herbal composition for providing a beneficial effect to the respiratory tract. The composition includes Thyme Leaf, Wild Cherry Bark, Cocoa Extract, Mullein Leaf Extract, and Boswellia Serrata. In particular, the composition may prevent or treat cough, specifically caused by exposure to smoke. Also described are methods of using the herbal composition.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/415,106, filed on Nov. 18, 2010, the teachings of which are expresslyincorporated by reference.

STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT

Not Applicable

BACKGROUND

1. Field of the Invention

The present invention relates to a novel synergistic herbal compositionfor providing beneficial effects to the respiratory tract of a mammal.In particular, the herbal composition may be used for preventing andtreating cough, specifically caused by exposure to smoke. The herbs inthe present invention are a unique combination including, Thyme Leaf,Wild Cherry Bark, Cocoa Extract, Mullein Leaf Extract, and BoswelliaSerrata.

2. Background of the Invention

Disorders of the respiratory tract, caused by post-nasal drip, sinusinfections, gastrosoesophageal reflux (GERD), asthma, and medications,all can result in cough. However, there is no more specific and obviouscause of cough than smoke exposure. The act of coughing is a protectivereflex. But, persistent cough is abnormal, and can dramatically affectone's quality of life, when it becomes excessive and/or profound.Coughing due to smoke exposure, even second hand exposure can causesubstantial physical, as well as emotional harm. Millions of people, ona daily basis, smoke tobacco products, are exposed to second hand smoke,or are exposed to smoke cause by fires. Despite this fact, there is nocommercially available product that has been proven to beneficiallysupport the respiratory tract and, thus, reduce their tendency to cough.

It has been well documented that smoke exposure causes particledeposition, inflammatory changes, and excessive secretions in the entirerespiratory tract as well as bronchospasms and decreased ciliaryactivity in the lower respiratory tract. These disturbances all cancontribute to the severity of cough. In addition, it has been documentedthat only 25-40% of people who are exposed to smoke do, in fact, cough.It is believed that those people have overactive nicotine receptorsfound in the sensory nerve endings, located throughout the respiratorytract. It becomes obvious that to successfully alleviate cough, acombination product to treat each, and all of the respiratory tractdisturbances, become imperative.

Herbal products, in the form of nutritional supplements have been usedfor centuries to treat medical disorders. Since a void exists fortherapeutic products that actually work to support the respiratorytract, the use of herbal alternatives has gained greater attention.Furthermore, recent data has suggested that combinations of herbalsupplements, such as has been used in traditional Chinese Medicine, canprovide benefits to the respiratory tract. Allergic rhinitis and asthma,for example, have been shown to improve with this herbal combinationapproach.

Since there are a multitude of herbal products on the market, it becomesimperative to identify those products having a long history of safe use,as well as having had clinical studies that actually demonstrateeffectiveness. It is believed that combinations of these herbalsupplements can help reduce the tendency to cough by providingbeneficial effects to the respiratory tract, altered by smokeinhalation.

BRIEF SUMMARY

The present invention encompasses a synergistic herbal combination,potentially in the form of a chewable tablet or liquid, and is comprisedof five key ingredients that together support respiratory health. Thefive ingredients have been commercially available for health benefitsover the past several years. However, they have never been used inspecific combination. Each 2 oz liquid dose, or chewable tablet,contains the following ingredients: Thyme Leaf (Thymus vulgaris), WildCherry Bark (Prunus serotina), Cocoa Extract (Theobroma cacao), MulleinLeaf Extract (Verbascum densitflorum), and Boswellia Serrata. It iscontemplated that one may use commercially available herbal products toproduce the presently disclosed synergistic herbal combination product.In particular, one specific embodiment envisions an herbal compositionfor providing a beneficial effect to the respiratory tract of a mammal,including humans. The herbal composition may include the following as anactive ingredient: Thyme Leaf, Wild Cherry Bark, Cocoa Extract, MulleinLeaf Extract, and Boswellia Serrata. The herbal composition may be usedto prevent or treat cough caused by smoke. Notably this may be achievedby one or more of the following beneficial aspects of the composition:cough suppression, demulcent, anti-inflammatory effect, antispasmodic,antioxidant, expectorant action, and bronchospastic relief.

It is envisioned that the herbal composition of the present inventionmay be formulated and administered in various forms, including, but notlimited to dietary supplements, chewable tablets, and liquidformulations. In particular, the herbal composition may include variedand numerous inactive ingredients known within the art to improve theformulation, delivery, preservation, appearance, and administration ofthe active ingredient.

Although the herbal composition is contemplated to be used in varyingamounts of each herb, one particular embodiment utilizes a weight ratioof Thyme Leaf, Wild Cherry Bark, Cocoa Extract, Mullein Leaf Extract,and Boswellia Serrata about 1:3.75; 1; 1.875; 3:75. In particular, andfor the average adult human, the herbal composition may be formulated inthe following amounts: 40 mg. Thyme Leaf Extract, 50 mg. Wild CherryBark, 40 mg. Cocoa Extract, 75 mg. Mullein Leaf Extract, 150 mg.Boswellia Serrata. Alternatively, the herbal composition could beformulated in the following amounts 80 mg. Thyme Leaf Extract, 300 mg.Wild Cherry Bark, 80 mg. Cocoa Extract, 150 mg. Mullein Leaf Extract,300 mg. Boswellia Serrata. In these instances, a patient could take twodoses of the former to achieve the same results as a single dose of thelatter.

It is believed that a preferred embodiment of the present inventionwould be within the following ranges: 25-600 mg. Thyme Leaf, 25-600 mg.Wild Cherry Bark, 25-600 mg. Cocoa Extract, 25-600 mg. Mullein LeafExtract, 25-600 mg. Boswellia Serrata.

The present invention further contemplates a method of treating cough,caused by smoke, in a mammal by administering an effective amount of theherbal composition described herein to a mammal in need thereof. Inparticular, an adult human could receive beneficial effects by beingadministered, in chewable tablet or liquid form, the herbal compositionof the present invention, twice or thrice daily.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the various embodimentsdisclosed herein will be better understood with respect to the followingdescription and drawings, in which:

FIG. 1 shows a sample chart for objectively monitoring frequency andseverity of cough episodes.

DETAILED DESCRIPTION

The detailed description set forth below is intended as a description ofthe presently preferred embodiment of the invention, and is not intendedto represent the only form in which the present invention may beconstructed or utilized. The description sets forth the functions andsequences of steps for constructing and operating the invention. It isto be understood, however, that the same or equivalent functions andsequences may be accomplished by different embodiments and that they arealso intended to be encompassed within the scope of the invention.

One embodiment of the present invention encompasses a novel synergisticherbal composition that benefits the respiratory tract. In particular,the novel herbal composition of this embodiment is useful in preventingand/or treating cough caused by smoke.

The act of coughing is a complicated process. Disturbance of therespiratory tract can trigger neurohumoral consequences that,ultimately, may result in cough. The cough reflex is truly a protectivemechanism. However, when stimulated by smoke, the cough frequency andseverity can be greatly heightened, and dramatically affect one'squality of life.

Prior treatment outcomes for a large number of patients having chroniccough due to smoke inhalation remain dismal. There are several ways inwhich herbal ingredients may act to treat cough, e.g., 1) via centralnervous system action; 2) via local anesthetic effect 3) as a demulcent(soothing effect); 4) as a surfactant; 5) as an expectorant; 6) as amucolytic; 7) as a antispasmodic; 8) as an anti-inflammant; 9) as anantioxidant; 10) as an antihistamine; or 11) as a decongestant. Itwould, indeed, seem likely that combined effects provided by multipleherbal ingredients could have a greater chance of treatment success in apatient population in which no modality has previously worked.

There are many combination herbal cough preparations commerciallyavailable throughout the world. However, the novel herbal combination ofthe present invention represents the first time that a combinationherbal cough product has undergone both subjective as well as objectiveoutcome measurement in people chronically exposed to smoke.

Components of the Herbal Composition

The novel herbal composition of the present invention includes thefollowing active ingredients: Thyme Leaf, Wild Cherry Bark, CocoaExtract, Mullein Leaf Extract, and Boswellia Serrata. Each of the listedactive ingredients will be discussed in greater detail below.Furthermore, along with the active ingredients, it is contemplated thatadditional inactive ingredients, such as but not limited to carriers,adjuvants, diluents, fillers, emulsifiers, preservatives, and flavoringagents, may be added to the composition to prepare the composition in asuitable form for administration to a patient, e.g., tablet form.

Thyme (Thymus vulgaris) is a leaf extract that contains volatile oils,such as thymol, as well as flavonoids (plant pigments). As a result,thyme commonly is used as an antitussive and antispasmodic. It alsocontains terpines that stimulate the cilia (fine hair-like structures inthe lower respiratory tract) to beat and increase mucous movement to theupper respiratory tract (expectorant action). Furthermore, it has ananti-inflammatory effect, resulting in decreased nitric oxideproduction.

Wild Cherry Bark (Prunus serotina) is a tree bark extract that containsprunasin, a potent cough suppressant. It has also been reported to havean antioxidant effect. Wild Cherry Bark has, furthermore, beendemonstrated to have a mild sedative effect, desirable during periods ofillness.

Cocoa Extract (Theobroma cacao) contains tannins, purine alkaloids,flavonoids, and caffeine. The components of the cocoa extract produceantitussive, antispasmodic, as well as anti-inflammatory effects.

Mullein Leaf Extract (Verbascum densiflorum) contains mucilage,saponins, and flavonoids. It also has anti-inflammatory and expectorantaction.

Boswellia Serrata is a tree resin gum that has significantanti-inflammatory effects. It has also been demonstrated to producebronchial dilation.

All of the above listed compounds are known and available to thosewithin the art. In the clinical trial below, the compounds were obtainedfrom GMP Laboratories of Anaheim, Calif.

EXAMPLE 1 Components and Effective Ranges

The components and effective dose ranges of the herbs used in herbalcomposition of the present invention are shown in Table 1.

TABLE 1 Effective Dose Range Ingredient Weight (mg) Thyme Leaf 25-600Wild Cherry Bark 25-600 Cocoa Extract 25-600 Mullein Leaf Extract 25-600Boswellia Serrata 25-500Table 2 shows a first example of a 2 oz liquid dose formulation of thepresent invention, wherein the 2 oz liquid dose also contains theinactive ingredients.

TABLE 2 First Example, 2 oz Liquid Dose Ingredient Weight (mg) ThymeLeaf 40 Wild Cherry Bark 150 Cocoa Extract 40 Mullein Leaf Extract 75Boswellia Serrata 150Table 3 shows a second example of a chewable tablet formulation of thepresent invention. In particular, the formulation of Table 3 is theformulation used in the clinical study described below.

TABLE 3 Second Example, One Chewable Tablet Ingredient Weight (mg) ThymeLeaf 150 Wild Cherry Bark 150 Cocoa Extract 40 Mullein Leaf Extract 60Boswellia Serrata 150Suggested dosing for the described tablets to an average human patientwould thus be 1-2 tablets, or a 2 oz liquid dose, 2-3 times a day.

EXAMPLE 2 Clinical Study 1. Patients

Eligible candidates were identified from a database of adult patientswho had sought care at The Cough Center, in Laguna Hills, Calif. in2009. A total of 5 patients (2 women and 3 men) with cough thatpersisted unabated for several years (chronic cough) were studied. Allsubjects shared a common history: 1) each had a 2 pack per day smokinghistory; 2) their cough profoundly diminished their quality of life; and3) no medication(s) other than narcotic derivatives were ever able toalleviate their cough. The patients had previously undergone a completeevaluation and treatment program, following the guidelines establishedby The American College of Chest Physicians. All patients were providedwith written information prior to obtaining consent.

2. Study Design

The subjects participated in a three week study. Patients with severeand chronic cough, and whom had smoked cigarettes for several years,were chosen. In this patient population, any improvement, even a smallimprovement, can be viewed as being statistically significant. Becausethe combination herbal product had such a unique taste, adequate placebocontrols were difficult to devise. Regardless, it has been a welldocumented fact that placebo responses in chronic cough patients simplydo not occur. This is possibly due to the prolonged duration of symptomsand multiple previous therapeutic trials. Therefore, patients withchronic cough serve as their own control.

Preceding the study, each patient underwent an initial office evaluationto rule out any recent or unrecognized cause of cough, other thansmoking. All cough suppressants decongestants, antihistamines,anti-inflammatories, expectorants, and narcotics were eliminated priorto the study.

Each patient was required to take one chewable tablet of the combinationherbal product as described in Table 3, twice daily. At the end of thethree week period of treatment, another office evaluation was performed.Subjective, as well as objective measurement techniques, were thenadministered at each office visit to determine success of treatment.

Each tablet contained Thyme Leaf Extract (Thymus Vulgaris) 150 mg. WildCherry Bark (Prunus serotina) 150 mg. Cocoa Extract (Theobroma Cacao) 40mg., Mullein Leaf Extract (Verbascum Densiflorum) 60 mg., and BoswelliaSerrata 150 mg.

3. Clinical Evaluation

The goal of successful treatment was cough resolution or cough reducedto the extent that it was no longer dominating one's quality of life(QOL). The assessment of treatment success was based on the positivetrends noted with both subjective and objective evaluation. At pre- andpost-treatment evaluations, a subjective measurement was attained usingthe Leicester Cough-Specific QOL Questionnaire, as described in thearticle Development of a Symptom Specific Healthy Status for Patientswith Chronic Cough; Leicester Cough Questionnaire (LCQ) by Birring etal., published in Thorax 2003; 58: 339-343. The questionnaire provides avalidated and reproducible measure of the impact of chronic cough onactivities of daily living. The subjects score the 19-item questionnairebased on physical, social, and psychological effects of cough. Anobjective system of cough monitoring was devised to assess bothfrequency and severity of coughing (FIG. 1). It should be noted thatcough episodes or “epochs” were recorded rather than each individualcough. This system of evaluation became necessary because 1) a coughmonitor for the many patients was impractical; 2) there is a widedifference of opinions as to what constitutes an individual “coughsound”; 3) the impact of coughing episodes seems to be recalled moreaccurately than each individual cough; and 4) the severity of coughingmay have more of an impact than that of frequency of episodes. Eachcategory of evaluation, frequency, severity, and Leicester QOL (LQOL)score was given equal weighting when treatment success was determined.For example, if frequency of episodes decreased 80-100%, severitydiminished 75-100%, and LQOL score changed >2.6 points, then thatindividual would be categorized as being “improved”. If frequency ofepisodes decreased 0-10%, severity diminished 0-15%, LQOL score changed<1.3 points, then that individual would be categorized as being “notimproved”. Individuals with values in between those two extremes werecategorized as being “somewhat improved”.

4. Statistical Analysis

Data for age and cough duration were expressed as median (range) values.Response rates were analyzed by paired T-tests. Group comparisons wereperformed using the Fisher two-tailed exact test. A value of p<0.05 wasconsidered statistically significant.

5. Results

A total of 5 patients were initially enrolled in the study with a median(SD) age of 54 (10.2) years were studied. The median duration of coughwas 5years (60 months) with a range of 2 months to 60 years. Two of thefive patients were female, three were male. Of the 5 patients, none hadadverse side effects. All patients completed the three week study.

Upon evaluation, it was determined that 4 of the 5 patients studied(80%) demonstrated a statistically significant improvement in thefrequency, severity, and subjective assessment of their quality of life,with the use of the combination herbal product. Of the 4 “improved”patients, 3 were “much improved” and 1 were “somewhat improved.”Unfortunately, the cough for 1 patient was “not improved”. The threepatients that had marked improvement had immediate improvement withinone hour of digestion of the chewable tables identified in Example 2.

6. Conclusion

The results of this study showed that this particular novel combinationherbal product can make a significant difference in the cough managementin many patients chronically exposed to smoke with which no othertreatment, short of (or including) narcotics, was successful.Furthermore, it has been demonstrated that the novel combination herbalproduct can be tolerated well, causing no side effects. Of greatestimportance, however, is the fact that the novel combination herbalproduct has been shown to make a statistically significant improvementin the quality of life in patients having persistent cough caused byexposure to smoke.

The above description is given by way of example, and not limitation.Given the above disclosure, one skilled in the art could devisevariations that are within the scope and spirit of the inventiondisclosed herein, including varying the amounts of each herbalcomposition and including additional inactive ingredients to make thecomposition more suitable for administration to a patient. Further, thevarious features of the embodiments disclosed herein can be used alone,or in varying combinations with each other and are not intended to belimited to the specific combination described herein. Thus, the scope ofthe claims is not to be limited by the illustrated embodiments.

1-10. (canceled)
 11. A method of treating cough in a mammal, the methodcomprising administering an effective amount of an active ingredientconsisting essentially of Thyme Leaf, Wild Cherry Bark, Cocoa Extract,Mullein Leal Extract, and Boswellia Serrata to a mammal in need thereof.12. The method of claim 11, wherein the mammal is a human.
 13. Themethod of claim 11, wherein the active ingredient consists essentiallyof 25-600 mg, ‘Thyme Leaf, 25-600 mg, Wild Cherry Bark, 25-600 mg. CocoaExtract, 25-600 mg. Mullein Leaf Extract, and 25-600 mg. BoswelliaSerrata.
 14. The method of claim 13, wherein the active ingredientconsists essentially of 80 mg. Thyme Leaf, 300 mg. Wild Cherry Bark, 80mg. Cocoa Extract, 150 mg. Mullein Leaf Extract, and 300 mg. BoswelliaSerrata.
 15. The method of claim 14, wherein the active ingredient isadministered twice daily.
 16. The method of claim 14, wherein the activeingredient is administered thrice daily.
 17. The method of claim 11,wherein the active ingredient is administered to the mammal in chewabletablet or liquid.